utritional Evaluation and Optimisation in Neonates
Completed
- Conditions
- Preterm birthPregnancy and Childbirth
- Registration Number
- ISRCTN29665319
- Lead Sponsor
- Imperial College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
1. Preterm infants (either sex) born below 31 weeks of gestation (defined as less than or equal to 30 weeks and 6 days)
2. Written informed consent from parents
Exclusion Criteria
1. Major congenital or life threatening abnormalities
2. Inability to randomise in time to allow administration of trial parenteral nutrition (PN) within 24 hours of birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. For the amino acid intervention: non-adipose (lean) body mass measured by whole body MRI at term age equivalent<br>2. For the lipid intervention: hepatic magnetic resonance spectroscopy (MRS) to measure IHCL at term age equivalent
- Secondary Outcome Measures
Name Time Method 1. Anthropometry (weight, length and head circumference) measured at term age equivalent<br>2. Brain MRI (brain volumes, white matter apparent diffusion co-efficient values, cerebral vessel tortuosity) measured at term age equivalent<br>3. Metabolic index of insulin resistance at term age equivalent (quantitative insulin-sensitivity check index [QUICKI]), calculated using fasting serum glucose and insulin<br><br>Added 07/12/2009:<br>4. Ratio of internal to subcutaneous adipose tissue at term age equivalent. <br>5. Serum triglyceride and serum bilirubin levels.<br><br>Added 11/05/2010: <br>6. Metabonomic profile <br>7. Incidence of death <br>8. Number of infants with incomplete follow-up<br><br>Added 24/03/2011:<br>9. Inflammatory markers and lipid profile